Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).

• Sponsor: Can-Am HIFU Inc. (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05201131
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 86.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

To document the clinical outcome of Rezūm therapy for BPH patient in Canadian cohort.

Condition or Disease	Intervention/Treatment	Phase
Urologic Diseases	Procedure: Rezum

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Canadian Cohort of Convective Thermal Therapy Using Rezūm System in Benign Prostatic Hyperplasia (BPH).
• Actual Study Start Date: Oct 7, 2019
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Rezum procedure	Procedure: Rezum; Rezum

Outcome Measures

Primary Outcome Measures

1. Maximum flow rate (Q-max) [Baseline]

   Maximum flow rate (Q-max)

2. Change of Maximum flow rate (Q-max) [1 month after surgery]

   Change of Maximum flow rate (Q-max)

3. Change of Maximum flow rate (Q-max) [3 months after surgery]

   Change of Maximum flow rate (Q-max)

4. Change of Maximum flow rate (Q-max) [6 months after surgery]

   Change of Maximum flow rate (Q-max)

5. Change of Maximum flow rate (Q-max) [12 months after surgery]

   Change of Maximum flow rate (Q-max)

6. Change of Maximum flow rate (Q-max) [24 months after surgery]

   Change of Maximum flow rate (Q-max)

7. Change of Maximum flow rate (Q-max) [36 months after surgery]

   Change of Maximum flow rate (Q-max)

8. Post-Void Residual (PVR) volume [Baseline]

   Post-Void Residual (PVR) volume

9. Change of Post-Void Residual (PVR) volume [1 month after surgery]

   Change of Post-Void Residual (PVR) volume

10. Change of Post-Void Residual (PVR) volume [3 months after surgery]

    Change of Post-Void Residual (PVR) volume

11. Change of Post-Void Residual (PVR) volume [6 months after surgery]

    Change of Post-Void Residual (PVR) volume

12. Change of Post-Void Residual (PVR) volume [12 months after surgery]

    Change of Post-Void Residual (PVR) volume

13. Change of Post-Void Residual (PVR) volume [24 months after surgery]

    Change of Post-Void Residual (PVR) volume

14. Change of Post-Void Residual (PVR) volume [36 months after surgery]

    Change of Post-Void Residual (PVR) volume

15. Prostate Volume measured by transrectal ultrasound (TRUS) [Baseline]

    Prostate Volume measured by transrectal ultrasound (TRUS)

16. Change of Prostate Volume measured by transrectal ultrasound (TRUS) [12 months after surgery]

    Change of Prostate Volume measured by transrectal ultrasound (TRUS)

17. Questionnaire [Baseline]

    IPSS

18. Change of Questionnaire [1 month after surgery]

    Change of IPSS score

19. Change of Questionnaire [3 months after surgery]

    Change of IPSS score

20. Change of Questionnaire [6 months after surgery]

    Change of IPSS score

21. Change of Questionnaire [12 months after surgery]

    Change of IPSS score

22. Change of Questionnaire [24 months after surgery]

    Change of IPSS score

23. Change of Questionnaire [36 months after surgery]

    Change of IPSS score

24. Adverse Events [Baseline]

    Adverse Events

25. Change of Adverse Events [1 month after surgery]

    Change of Adverse Events

26. Change of Adverse Events [3 months after surgery]

    Change of Adverse Events

27. Change of Adverse Events [6 months after surgery]

    Change of Adverse Events

28. Change of Adverse Events [12 months after surgery]

    Change of Adverse Events

29. Change of Adverse Events [24 months after surgery]

    Change of Adverse Events

30. Change of Adverse Events [36 months after surgery]

    Change of Adverse Events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male subjects of ≥ 18 years of age.

• Primary diagnosis of Benign Prostate Hypertrophy (BPH).

• Candidate for Rezūm therapy as per clinical decision of Investigator.

• Willing and able to accurately complete the required questionnaires.

• Willing and able to provide signed and dated informed consent

Exclusion Criteria:

• Characteristics indicating a poor compliance with study protocol requirements.

• Disease or other health condition that is not suitable for this study.

• Unable or unwilling to provide signed informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dean Elterman	Toronto	Ontario	Canada	M5T 2S8

Sponsors and Collaborators

• Can-Am HIFU Inc.

Investigators

• Principal Investigator: Dean Elterman, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dean Elterman, Urologist, Can-Am HIFU Inc.
• ClinicalTrials.gov Identifier: NCT05201131
• Other Study ID Numbers: Rezum in BPH CAN
• First Posted: Jan 21, 2022
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dean Elterman, Urologist, Can-Am HIFU Inc.: benigh prostate hypertrophy
• Additional relevant MeSH terms: Prostatic Hyperplasia; Urologic Diseases; Hyperplasia

Study Results

No Results Posted as of Jan 21, 2022